Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| W8M-MC-LAA2 | Other Identifier | Eli Lilly and Company | |
| W8M-MC-CWMM Master Protocol | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3841136 Dose 1 | Experimental | Participants will receive LY3841136 subcutaneously (SC) |
|
| LY3841136 Dose 2 | Experimental | Participants will receive LY3841136 SC |
|
| LY3841136 Dose 3 | Experimental | Participants will receive LY3841136 SC |
|
| LY3841136 Dose 1 + Tirzepatide Dose 1 | Experimental | Participants will receive LY3841136 SC and Tirzepatide SC |
|
| LY3841136 Dose 2 + Tirzepatide Dose 1 | Experimental | Participants will receive LY3841136 SC and Tirzepatide SC |
|
| LY3841136 Dose 2 + Tirzepatide Dose 2 | Experimental | Participants will receive LY3841136 SC and Tirzepatide SC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3841136 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Body Weight | Baseline, Week 48 | |
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Week 48 | |
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction |
Not provided
Inclusion Criteria:
W8M-MC-LAA2
W8M-MC-CWMM:
Exclusion Criteria:
W8M-MC-LAA2
Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
Have an on-going or history of bradyarrhythmia and/or sinus bradycardia
Have an elevated resting pulse rate (mean >100 beats per minute (bpm)) or reduced resting pulse rate (mean <60 bpm) at screening
Have any of the following cardiovascular conditions within 6 months prior to screening:
Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliters per minute (mL/min)/1.73 m2
Have a history of acute or chronic pancreatitis
Have fasting triglycerides >500 milligrams per deciliter (mg/dL) (5.7 mmol/L) at screening
All concomitant medications should be at a stable dose for at least 3 months prior to screening
W8M-MC-CWMM
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute for Liver Health II dba Arizona Clinical Trials - Mesa | Chandler | Arizona | 85225 | United States | ||
Not provided
| Label | URL |
|---|---|
| A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
|
| LY3841136 Dose 3 + Tirzepatide Dose 3 | Experimental | Participants will receive LY3841136 SC and Tirzepatide SC |
|
| Tirzepatide Dose 3 | Active Comparator | Participants will receive Tirzepatide SC |
|
| LY3841136 Dose 2 + Tirzepatide Dose 3 | Experimental | Participants will receive LY3841136 SC and Tirzepatide SC |
|
| Placebo | Placebo Comparator | Participants will receive placebo administered SC. |
|
| Tirzepatide | Drug | Administered SC |
|
| Placebo | Drug | Administered SC |
|
| Week 48 |
| Change from baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 48 |
| Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136 | Baseline, Week 48 |
| PK: Maximum Concentration (Cmax) of LY3841136 | Baseline, Week 48 |
| HOPE Research Institute |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Headlands Research - Scottsdale | Scottsdale | Arizona | 85260 | United States |
| The Institute for Liver Health II dba Arizona Liver Health-Tucson | Tucson | Arizona | 85712 | United States |
| NorCal Medical Research, Inc | Greenbrae | California | 94904 | United States |
| Velocity Clinical Research, Huntington Park | Huntington Park | California | 90255 | United States |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | United States |
| Northeast Research Institute (NERI) | Fleming Island | Florida | 32003 | United States |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| Charter Research - Winter Park | Orlando | Florida | 32803 | United States |
| Charter Research - Lady Lake | The Villages | Florida | 32162 | United States |
| Medical Research Partners | Ammon | Idaho | 83406 | United States |
| Great Lakes Clinical Trials - Andersonville | Chicago | Illinois | 60640 | United States |
| Great Lakes Clinical Trials - Ravenswood | Chicago | Illinois | 60640 | United States |
| NorthShore University Health System | Skokie | Illinois | 60077 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50266 | United States |
| Cotton O'Neil Diabetes & Endocrinology | Topeka | Kansas | 66606 | United States |
| Knownwell | Needham | Massachusetts | 02492 | United States |
| Lucida Clinical Trials | New Bedford | Massachusetts | 02740 | United States |
| Headlands Research - Detroit | Southfield | Michigan | 48034 | United States |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Clinvest Headlands Llc | Springfield | Missouri | 65807 | United States |
| Las Vegas Medical Research | Las Vegas | Nevada | 89128 | United States |
| Dent Neurologic Institute | Amherst | New York | 14226 | United States |
| Velocity Clinical Research, Syracuse | East Syracuse | New York | 13057 | United States |
| North Suffolk Neurology | Port Jefferson Station | New York | 11776 | United States |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | United States |
| Medication Management | Greensboro | North Carolina | 27405 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Lucas Research, Inc | Morehead City | North Carolina | 28557 | United States |
| Lucas Research, Inc. | New Bern | North Carolina | 28562 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Tribe Clinical Research, LLC | Greenville | South Carolina | 29607 | United States |
| Quality Medical Research | Nashville | Tennessee | 37211 | United States |
| IMA Clinical Research Austin | Austin | Texas | 78745 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| FutureSearch Trials of Dallas | Dallas | Texas | 75251 | United States |
| PlanIt Research, PLLC | Houston | Texas | 77079 | United States |
| Tekton Research - Fredericksburg Road | San Antonio | Texas | 78229 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78240 | United States |
| Texas Valley Clinical Research | Weslaco | Texas | 78596 | United States |
| Spectrum Medical, Inc. | Danville | Virginia | 24541 | United States |
| Central Washington Health Services Association d/b/a Confluence Health | Wenatchee | Washington | 98801 | United States |
| Centro de Investigaciones Metabólicas (CINME) | Buenos Aires | C1056ABI | Argentina |
| Centro Médico Viamonte | Buenos Aires | C1120AAC | Argentina |
| Consultorio de Investigación Clínica EMO SRL | Buenos Aires | C1405BUB | Argentina |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Buenos Aires | C1425AGC | Argentina |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
Not provided
Not provided